Durham,
North Carolina
27710
Purpose:
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in
treating patients who have brain metastases.
Study summary:
OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of 131-iodine-labeled
monoclonal antibody fragment Me1-14 F(ab')2 administered intrathecally in patients with
neoplasms metastatic to the leptomeninges. II. Identify objective therapeutic responses to
this treatment.
OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 F(ab')2,
131I-Me1-14 F(ab')2.
PROJECTED ACCRUAL: Three to 6 patients will be treated at each dose studied.
Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed neoplasm that is recurrent in the
subarachnoid space Biopsy of recurrent lesion required if original diagnosis made more
than 2 years prior to entry and CSF cytology negative Radiographic evidence of measurable
lesion in the leptomeninges (by myelography, CT, or MRI) or cytologic evidence of
malignancy in the CSF Any type of neoplasm eligible provided tumor cells (tissue or CSF
preparation) bind significantly to intact monoclonal antibody Me1-14 IgG2a or to Me1-14
F(ab')2 Patency of subarachnoid pathways demonstrated by isotopic intraventricular flow
PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100%
Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least
100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal (ULN) Alkaline
phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.2 mg/dL Other: No
allergy to iodine Not pregnant or nursing
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior antineoplastic chemotherapy unless unequivocal evidence of tumor progression
No concurrent systemic chemotherapy Endocrine therapy: Corticosteroids allowed if at
lowest possible dose and stable for at least 10 days prior to entry Radiotherapy: At least
3 months since prior radiotherapy to site of measurable disease unless unequivocal
evidence of disease progression Surgery: Not specified